FDA.report

Wagotrix

Primary DI
00850028211410
Brand
Wagotrix
Company
GoldenDent
Model
WGSMEK
Catalog number
WGSMEK
Device description
WagoTrix Sectional Matrix System Essential Kit (excludes instruments)
Published
2021-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EJBHANDLE, INSTRUMENT, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850028211410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850028211410008500282114108500282114100850028211410

GMDN Terms

TermDefinition
Dental matrix band kitA collection of non-sterile devices intended for the temporary introduction of a dental matrix band to form a mould around a tooth prior to tooth restoration using a direct restorative material (not included). Often referred to as a dental matrix system, it includes a matrix band(s), matrix band tensioner, dental wedge, and appropriate forceps. This device is reusable after appropriate cleaning/sterilization of the reusable instruments, and when the consumable products have been replenished.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
078273228
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850011211939GoldenDentGO AGKGO AGK2021-02-26
00850011211946GoldenDentGO GKIGO GKI2021-02-26
00850011211014GoldenDentFS BFEFS BFE2021-02-25
00850011211021GoldenDentFS EF1FS EF12021-02-25
00850011211038GoldenDentFS EF2FS EF22021-02-25
00850011211045GoldenDentFS FSSFS FSS2021-02-25
00850011211052GoldenDentFS IA1FS IA12021-02-25
00850011211069GoldenDentFS IA2FS IA22021-02-25
00850011211076GoldenDentFS MTSFS MTS2021-02-25
00850011211083GoldenDentFS NCCFS NCC2021-02-25
00850011211090GoldenDentFS NCSFS NCS2021-02-25
00850011211106GoldenDentFS NTCFS NTC2021-02-25
00850011211113GoldenDentFS NTSFS NTS2021-02-25
00850011211120GoldenDentFS NUSFS NUS2021-02-25
00850011211137GoldenDentRS RFURS RFU2021-02-25
00850011211144GoldenDentFS SFCFS SFC2021-02-25
00850011211151GoldenDentFS TFUFS TFU2021-02-25
00850011211168GoldenDentGBSBGBSB2021-02-25
00850011211175GoldenDentGBSOGBSO2021-02-25
00850011211182GoldenDentGCCBGCCB2021-02-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
G149TBSB71050TBS BASICSACME ENTERPRISE.EJB2026-05-22
G149TBSB71060TBS BASICSACME ENTERPRISE.EJB2026-05-22
G149TBSB71070TBS BASICSACME ENTERPRISE.EJB2026-05-22
G149TBSB71080TBS BASICSACME ENTERPRISE.EJB2026-05-22
00348783010206Premier Mirror HandlesPREMIER DENTAL PRODUCTS COMPANYEJB2026-03-17
G1493807306TBS DentalACME ENTERPRISE.EJB2026-03-02
00841013120459Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
00841013120466Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
30371347019668Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019675Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019682Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019699Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017724Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017748Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00883205032164Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-21
00883205032157Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-19
08806343925183ever KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925213TAPER KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925220GUIDE KITShinhung MST Co., Ltd.EJB2025-07-28
08057639710567Specialist OrganizerMC BIO SRLEJB2025-06-23
08057639710574Tip with Indexable StopMC BIO SRLEJB2025-06-23
08057639710598Offset Tip SPMC BIO SRLEJB2025-06-23
08057639710604Long Tip SPMC BIO SRLEJB2025-06-23
08057639710628GBR MODULAR SETMC BIO SRLEJB2025-06-23
08057639712066Handle - Straight MDFMC BIO SRLEJB2025-06-23
08057639712073Handle - Straight - ErgalMC BIO SRLEJB2025-06-23
08057639712080Handle - Straight SP (TiN)MC BIO SRLEJB2025-06-23
08057639712097Handle - Asym. - ErgalMC BIO SRLEJB2025-06-23
08057639712103Handle - Asym. - SP (TiN)MC BIO SRLEJB2025-06-23
08057639712110Handle - Asym. - TitaniumMC BIO SRLEJB2025-06-23